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Data management plan

CRF design, annotations and validation


Data Management Committee & Study Support Center

Queries generation, DCF submittion

PhV handling & Safety Reports

CDISC, SDTM and ODM standards

Statistical Analysis

PhV handling & Safety Reports

Special process is established for reconciliation and handling of adverse effects. Infoset ensures that proper SAE form has been submitted electronically to the sponsor's PV or other authorities through notification report emails with integrated confirmation. In addition study progress is monitored at safety level by reports that describe the full status down to the patient level. Through i-CDMS all kind of safety reports (DSUR, PSUR etc.) can be provided on demand or periodically.